The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US

Inclusion Criteria:

1. Subjects, ages 18-70, inclusive.

2. Availability for the six-week duration of the clinical research study.

3. Good general health.

4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).

5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and
Silness Gingival Index.

6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein
Plaque Index (Turesky Modification).

7. Signed Informed Consent Form

Exclusion Criteria:

1. Presence of orthodontic bands.

2. Presence of partial removable dentures.

3. Tumor(s) of the soft or hard tissues of the oral cavity.

4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss
of periodontal attachment or alveolar bone).

5. Five or more carious lesions requiring immediate restorative treatment.

6. Antibiotic use any time during the one month prior to entry into the study.

7. Participation in any other clinical study or test panel within the one month prior to
entry into the study.

8. Dental prophylaxis during the past two weeks prior to baseline examinations.

9. History of allergies to oral care/personal care consumer products or their
ingredients.

10. On any prescription medicines that might interfere with the study outcome.

11. An existing medical condition which prohibits eating or drinking for periods up to 4
hours.

12. History of alcohol or drug abuse.

13. Pregnant or lactating subjects.